The Dietary Supplement cGMP Rule (21 CFR part 111)
Attend this 60 minutes presentation to gain a fundamental understanding of FDA's regulation of Dietary Supplements, Dietary supplements are regulated products, also Dietary supplement marketing, manufacturing, labeling, and advertising are all covered by regulations enforced by FDA.
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FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
Why should you Attend:
- Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations
- FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market
To gain a fundamental understanding of dietary supplement cGMPs .
Areas Covered in the Session:
Who Will Benefit:
- Definition of dietary supplement
- Current Good Manufacturing Practices
- Regulatory Professionals Working in the Field of Dietary Supplements
- Compliance Manager
- Validation Manager
- Regulatory Manager
- QC Managers
- QA Managers
Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.
Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products.
Dr. Colonna's consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.